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U.S. Department of Health and Human Services

Product Classification

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Respirator
 
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Product
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Device
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Regulation
Number
sort by regulation number [0-9]
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Device
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QXA
lateral flow immunochromatography assay for host biomarkers of respiratory infection  
866.3230 2
QWF
tubing, long term support greater than 6 hours Extracorporeal circuit and accessories f...
870.4100 2
QQX
respiratory specimen nucleic acid sars-cov-2 test  
866.3981 2
QOP
respiratory humidifier for emergency use  
not classified
QOK
hardware and software for optical camera-based mea ... Hardware and software for optical camera...
870.2786 2
QOF
multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents  
866.3981 2
QOD
extracorporeal circuit and accessories for long term respiratory cariodpulmonary failure  
not classified
QNR
blood pump for ecmo, long-term (> 6 hours) use Extracorporeal circuit and accessories f...
870.4100 2
QME
software for optical camera-based measurement of p ... Software for optical camera-based measur...
870.2785 2
QLT
covid-19 multi-analyte respiratory panel nucleic acid devices  
not classified
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